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StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy

NCT02765997•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.

Eligibility

Age

2 - 35 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose \>2.5 x 107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing).
•Eligible Diseases
•* Acute myelogenous leukemia (AML) at the following stages:
•* Intermediate to high risk leukemia in first complete remission (CR1) based on institutional criteria.
•* Any second or subsequent CR.
•* Secondary AML with prior malignancy that has been in remission for at least 12 months.
•* Acute lymphocytic leukemia (ALL) at the following stages:
•* High risk first remission.
•1. Ph+ ALL, or
•2. MLL rearrangement with slow early response at Day 14, or
+16 more criteria

Exclusion Criteria

•Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
•Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
•Active bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms).
•Prior autologous or allogeneic transplant within past 12 months.
•Other active malignancy.
•Inability to receive TBI 1320 cGy (e.g., extensive prior therapy including \>12 months alkylator therapy or \>6 months alkylator therapy with extensive radiation. Or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.

Locations (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

April 1, 2017

Primary Completion Date

June 1, 2020

Completion Date

June 1, 2022

Last Updated

December 5, 2017

Conditions

Acute Myeloid LeukemiaAcute Lymphocytic LeukemiaChronic Myelogenous LeukemiaMyelodysplasia

Interventions

Unmanipulated UCB

BIOLOGICAL

SR-1 UCB

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias